WHO TRS (Technical Report Series) 981, 2013 Annex 4

Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products

1. Definitions:

Collaborative procedure (Procedure) Procedure for collaboration between the WHO Prequalification of Medicines Programme (WHO/PQP) and interested national medicines regulatory authorities (NMRAs) in the assessment and accelerated national registration of WHO prequalified pharmaceutical products.

Participating authorities or participating NMRAs

NMRAs that voluntarily agree to implement this collaborative procedure and accept the task of processing applications for registration of WHO-prequalified pharmaceutical products in accordance with the terms of the Procedure. A list of participating authorities is posted on the WHO/PQP web site (http://www.who.int/prequal/).

2. Background information:

National assessment of applications for registration of pharmaceutical products (marketing authorization) is the key regulatory process that enables NMRAs to evaluate and monitor the quality, safety and efficacy of pharmaceutical products. For most countries the approach to registration of pharmaceutical products is a combination of two components:

■ the NMRA's own assessment of application documentation combined with verification of compliance with relevant good practices by inspections (mostly focusing on good manufacturing practices (GMP) and inspections of manufacturing sites);

■ consideration by the NMRA of decisions and outcomes of assessments and inspections made by NMRAs in other countries.

Consideration of the outcomes of assessments and inspections by trusted authorities substantially contributes to savings in regulatory resources and improvements in the quality of regulatory decisions, while retaining the prerogative of NMRAs to conclude their assessment by sovereign decisions, which reflect their own judgement of the benefit–risk balance as it relates to their specific country situation and the legislation in place.

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WHO TRS (Technical Report Series) 981, 2013 Annex 4: